ISO 10993-2 PDF

ISO 10993-2 PDF

\\FS09\USER\RUF\ISO\TC \normen\\Revision \EN_ISO_ 2_(E) This document is not an ISO International Standard. Purchase your copy of BS EN ISO as a PDF download or hard copy directly from the official BSI Shop. All BSI British Standards. ISO. /(R) Biological evaluation of medical devices — Part 2: Animal welfare requirements. American. National. Standard.

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Arthur Brandwood has been involved as an Australian expert member of TC isoo and was present in Mishima. In the 25th anniversary meeting of TC some substantial revisions to the current ISO series were made.

Separately work is underway to introduce non animal based test methods for genotoxicity, irritation and sensitization. Work on an vitro sensitization assays is at an earlier stage — with consideration of up to 16 alternate assays — and a likely outcome being a panel of in vitro assays for assessment of sensitization in place of the current Guinea Pig maximisation assay.

Animal assays will be with us for a while yet — but TC is making real progress on non-animal alternatives. ISO does not deal well with biological evaluation of respiratory devices — such as ventilators, masks and inhalers — which have indirect patient contact via 10993-2 gas pathway. The current approaches in Part 1 set out requirements which were 110993-2 intended for indirect blood contact devices such as infusion equipment.


ISO – Biological evaluation of medical devices — Part 2: Animal welfare requirements

This should provide a safety assessment approach based on assessment against acceptable limits of volatile organics and particulates which is not only cheaper and simpler to perform — but also much more robust and protective of the patient. A major revision of Part 17 on allowable limits for leachables is in the 1093-2.

The concept is straightforward — if it can be shown that an impurity is below the TTC, then it is assumed that the level of contamination is of no significant risk and no further evaluation is required with regard to that impurity.

TTC allows definition of threshold values for substances below which 19093-2 is insufficient material to cause a toxicological hazard and no further evaluation is required.

Medical Devices | VUOS a.s.

The concept may also be applied more generally to unidentified contaminants. The outcome was addition of MEM elution test to the Annex of the revision draft.

Pass fail criteria have now been deleted from the current draft, although there has been new content drafted on interpretation of quantitative MTT tests versus semi-quantitative methods. Part 18 was substantially revised and is now proposed to be converted from a Technical Specification to a full standard. ISO on blood compatibility is under revision with focus on a new haemolysis method currently under round robin evaluation.


Work is also underway on a new Annex on complement testing possible in vitro thrombogenicity models to replace the current canine model.

The outcome was to allow an extension of exemptions for haemodialysis to cover peritoneal dialysis and other blood purifiers. Need assistance in biological evaluation of your medical device? We can help you with developing your evaluation strategy, dealing with test laboratories and preparation of expert reports.

Medical Devices

May 9, admin. New content on postmarket monitoring and electronic records. An annex on risk management.

Guidance for ethics committees to support international recognition of ethics processes Guidance on GMP requirements for investigational devices — to reinforce the different approaches required for devices compared to medicines.

Update to Part 109933-2 to include Thresholds of Toxicological Concern. Nanomaterials, EO residues, hemolysis and more. On Extraction — the vagaries Dec 20, TC Wrap Up Dec 13,